The Siemens SC9000/SC9015 Series Medical Information Bus (MIB) Protocol Converter is intended to connect third party medical devices such as Siemens SV300™ ventilator, Baxter Vigilance™ blood gas/continuous cardiac output monitor, Siemens SV900™ ventilator, Puritan Bennett 7200™ ventilator, and the Draeger Evita IITM, Draeger Evita IV™ and Draeger Babylog™ ventilators that do not provide data per the IEEE 1073 Medical Information Protocol Standard to the Siemens SC9000/SC9015 Bedside Monitor for display.

The Siemens SC9000/SC9015 Series Medical Information Bus (MIB) Protocol Converter is indicated for use in an environment where patient care is provided by healthcare professionals (Physician, Nurse, Technician) when the professional determines that the Siemens SV300™ ventilator, Baxter Vigilance™ blood gas/continuous cardiac output monitor, Siemens SV900™ ventilator, Draeger Evita II™, Evita IVTM, and Draeger Babylog™ ventilators, and Puritan Bennett 7200™ ventilator should be connected to the Siemens SC9000/SC9015 Bedside Monitor for display.

Device Description

The Siemens SC9000/SC9015 Series Medical Information Bus (MIB) Protocol Converter transforms data generated by third party devices (e.g. ventilators, SvO2 devices and infusion pumps) into a common format per the IEEE 1073 Medical Information Protocol and transmits this data to the Siemens SC9000/SC9015 Bedside Monitor. Attachment cables specific to third party devices are offered as accessories.

AI/ML Overview

The provided text describes a 510(k) amendment for the Siemens SC9000/SC9015 Series Medical Information Bus (MIB) Protocol Converter. This document is a regulatory submission for a device that acts as an interface between third-party medical devices (like ventilators and blood gas monitors) and the Siemens SC9000/SC9015 Bedside Monitor.

Based on the information provided, this is a regulatory filing for a protocol converter (an interface device) and not a medical device that diagnoses or treats a condition and thus does not involve clinical effectiveness studies, acceptance criteria, or performance data in the same way a diagnostic or therapeutic device would. The submission focuses on substantial equivalence to a predicate device.

Therefore, many of the requested sections about acceptance criteria, study details, sample sizes, ground truth establishment, and MRMC studies are not applicable to the nature of this particular device and its regulatory filing.

However, I can extract the relevant information and explain why other sections are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

This section is not applicable in the traditional sense for this device. The regulatory submission focuses on demonstrating substantial equivalence in terms of intended use, operating environment, and technical specifications as a protocol converter, not on clinical performance metrics like sensitivity, specificity, or accuracy. The acceptance criteria would primarily relate to successful data conversion and transmission, which is assessed through non-clinical functional testing rather than clinical trials. The document explicitly states "Assessment of clinical performance data for equivalence: Not applicable."

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Transforms data per IEEE 1073 Medical Information Protocol	Complies with IEEE 1073.3.1 and 1073.4.1 Standards
Transmits data to Siemens SC9000/SC9015 Bedside Monitor correctly	Functional as a protocol converter as per intended use
Connects specified third-party devices	Intended to connect listed ventilators and blood gas monitor
No adverse effects on patient safety or device functionality	Substantially equivalent to predicate, implying safety

2. Sample size used for the test set and the data provenance

Not Applicable. As a protocol converter that facilitates data transfer, there isn't a "test set" of patient data in the clinical sense for evaluating diagnostic or therapeutic accuracy. The testing would be functional and engineering-based to ensure correct data conversion and transmission. The document doesn't detail any specific sample size for functional testing of the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. "Ground truth" in the context of clinical accuracy (e.g., disease presence) is not relevant for this device. The ground truth for this protocol converter would be the accurate transmission of data, which is typically verified through engineering validation and testing by qualified technical personnel, not clinical experts establishing disease ground truth.

4. Adjudication method for the test set

Not Applicable. Since there is no "test set" of clinical cases requiring ground truth establishment by clinical experts, there is no adjudication method described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This device is a hardware/software interface for data transfer, not an AI-powered diagnostic or therapeutic tool. Therefore, MRMC studies and AI assistance are irrelevant to its function and regulatory submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This device is a protocol converter. It's a "standalone" device in the sense that it operates as an interface, but its performance is measured by its ability to correctly convert and transmit data, not by clinical diagnostic accuracy in a standalone algorithm context. There is no algorithm performance to assess in the typical AI sense.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable. For this device, "ground truth" would relate to the correctness of data conversion and transmission according to the specified protocols (e.g., IEEE 1073). This is established through technical specifications and validation testing, not clinical findings or outcomes data.

8. The sample size for the training set

Not Applicable. This document pertains to a protocol converter, not a machine learning or AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not Applicable. As there is no training set, this question is not relevant.

Summary of Relevant Information from the Document:

Device Type: Medical Information Bus (MIB) Protocol Converter.
Purpose: Transforms data from third-party devices (e.g., ventilators, SvO2 devices, infusion pumps) into IEEE 1073 Medical Information Protocol format and transmits it to the Siemens SC9000/SC9015 Bedside Monitor for display.
Intended Use Environment: OR or ICU, connecting to specified ventilators and blood gas monitors.
Predicate Device: Hewlett-Packard Model M1032A Vuelink Interface Plug In Module (K923682).
Equivalence Claim: Substantial equivalence based on intended use, technology, and adherence to relevant standards.
Compliance Standards: IEEE 1073.3.1 - 1994 (Transport Profile - Connector Mode) and 1073.4.1 - 1994 (Physical Layer Interface - Cable Conn).
Clinical Data: Explicitly stated as "Not applicable" for equivalence assessment.
Testing Information: The submission states "Assessment of non-clinical performance data for equivalence" was done, implying functional and engineering testing, but specific details (e.g., sample sizes, specific test protocols) are not provided in this excerpt.

Summary

{0}------------------------------------------------

3)22 368 Amendment Siemens SC9000/SC9015 Medical Information Bus (MIB) Protocol Converter

510(k) AMENDMENT SUMMARY

as required per 807.92(c)

Submitters Name, Address:

4 1997

Siemens Medical Systems, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: (508) 750-7500 Fax: (508) 777-3398 Official Correspondent: David Simard, Director Quality Assurance & Regulatory Affairs Contact person for this submission: Jacqueline E. M. Emery Date amendment to 510(k) K970368 was prepared: August 8, 1997

Trade Name, Common Name and Classification Name: 3.

A. Trade Name: (Same as original submission)

Siemens SC9000/ SC9015 Series Medical Information Bus (MIB) Protocol Converter [510(k) K970368 cleared May 6, 1997]

B. Common Name, Classification Name, Class and Regulation Number:
(Same as original submission)

Common Name	ClassificationNumber	Class	Regulation Number
Transducer Signal amplifier and conditioner	73 DQA	II	21 CFR 870.2060

Predicate Device Identification: (Same as original submission) 4. Hewlett-Packard Model M1032A Vuelink Interface Plug In Module cleared under 510(K) number: K923682
1. Device Description: (Same as original submission)

6. Intended Use:

The Medical Information Bus (MIB) Protocol Converter is intended to connect third party medical devices such as Siemens SV300™ ventilator, Baxter Vigilance™ blood gas/continuous cardiac output monitor, Siemens SV900™ ventilator, Puritan Bennett 7200™ ventilator, and the Draeger Evita IITM, Draeger Evita IV™ and Draeger Babylog™ ventilators that do not provide data per the IEEE 1073 Medical Information Protocol Standard to the Siemens SC9000/SC9015 Bedside Monitor for display.

Siemens Medical Systems, Inc. Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923 USA

Tel: (508) 750-7500 Fax: (508) 777-3398 Telex: 511958 (Siemensm SD)

{1}------------------------------------------------

7. Table of Device Similarities and differences to predicate device (Same as original submission)

	Substantial Equivalent Device	Applicant
	Hewlett Packard Co	Siemens Medical Systems
	Model MI032A VueLink Module	SC9000/9015 Series MedicalInformation Bus (MIB) ProtocolConverter (Amendment)
Manufacturer	Hewlett Packard	Siemens Medical Systems -Electromedical Systems Group, PCS
510(k) Number	K923682	K970368 K973222
Intended Use	Provides an external device interfacecapability to third party devices thathave a serial RS-232 and/or analogoutput	Same
Intended Population	NANot connected to patients	Same
Intended Environment	OR or ICU	Same
Input port	RS-232, Analog, Analog/Digitalcombination	Same
Output port	HP specific	IEEE 1073 (MIB connector)

Assessment of non-clinical performance data for equivalence: (Same as original submission) 8. Substantial equivalence is claimed to the Hewlett Packard Model M1032A VueLink Interface Plug-In Module cleared under 510(k) number K923682.

Assessment of clinical performance data for equivalence: Not applicable 9. (Same as original submission)

Biocompatability: Not applicable (Same as original submission)
Sterilization: Not applicable (Same as original submission)
Standards and Guidances: (Same as original submission) Currently, there are no FDA standards for this device. However, the Siemens SC9000/SC9015 Series Medical Information Bus (MIB) Protocol Converter complies with:

1073.3.1 - 1994 IEEE Standard for Medical Device Communications -Transport Profile - Connector Mode -

1073.4.1 1994 IEEE Standard for Medical Device Communications ﺳ Physical Layer Interface - Cable Conn .
Siemens Medical Systems, Inc. Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923 USA

Tel: (508) 750-7500 Fax: (508) 777-3398 Telex: 511958 (Siemensm SD)

{2}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Mr. David Simard ~ · · · · · · Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers, Massachusetts 01923

K973222 Re: Siemens SC9000/SC9015 Series Medical Information Bus (MIB) Protocol Converter for the Puritan Bennett 7200™, the Draeger Evita II™, IV™, Babylog™, and Siemens SV900™ Ventilators Requlatory Class: II (two) Product Code: 73 DQA Dated: August 18, 1997 Received: August 21, 1997

Dear Mr. Cohen:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{3}------------------------------------------------

Page 2 - Mr. David Simard

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,
Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Page 1 of 1

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Siemens SC9000/SC9015 Series Medical Information Bus (MIB) Device Name:__________________________________________________________________________________________________________________________________________________________________ Protocol Converter

Indications for Use:-- ...... ................................................................................................................................................

MRI Compatibility Statement:

The Siemens SC9000/SC9015 Series Medical Information Bus (MIB) Protocol Converter is not compatible for use in an MRI magnetic field.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

	Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
	OR
	Over-The-Counter Use
	(Division Sign-Off)
	Division of Cardiovascular, Respiratory,
	and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).